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Studies

Derby CTSU is currently involved in a variety of research projects from study development to conduct and analysis. 

Below are a few examples of the studies we are supporting and details of the services that we offer.

Clinical investigation plan for the use of interactive binocular treatment (I-BiT) for the management of anisometropic, strabismic and mixed amblyopia in children aged 3.5 – 12 years

This study will aim to treat amblyopia (lazy eye) using novel 3-D computer technology and active shutter glasses. Computer games and DVD's are viewed through the active shutter glasses and are specially prepared to preferentially stimulate the lazy eye; the child can only play the games accurately if they are using their lazy eye, which, we hope, will help improve vision in the lazy eye. The study will be undertaken as a randomised control trial, with the control group receiving a further period of glasses only treatment (the treatment before entering the trial) or observation if glasses are not required and playing placebo games on a standard laptop. Patients will receive 6 weeks of treatment (30 minutes minimum of play time per day for 6 weeks in the treatment arm) and level of vision will be assessed after 6 weeks and compared with starting level of vision. Patients can return to standard care after the trial period which, at 6 weeks, should not impact negatively on their final outcome. 

Chief Investigator: Prof Alex Foss

EudraCT number: N/A

ISRCTN number/ Clinical Trials.gov Number: NCT02810847

Funder: National Institute for Health Research

Sponsor: Nottingham University Hospitals NHS Trust

Current Status: Open to recruitment

Derby CTSU Involvement: Study Design and Protocol Development, Data Management, Statistics

HaemoDialysis interventions to REduce Multi-Organ Dysfunction and Effect on quality of Life (HD-REMODEL) Assessed by MRI Scanning

The purpose of this study is to characterise in detail cardiac, cerebral and renal structure, function and perfusion in patients on haemodialysis using magnetic imaging techniques. The effects of a standard prescription haemodialysis (dialysate temperature 37°C) will be compared to a thermocontrolled (or isothermic) haemodialysis prescription to ascertain if thermocontrolled HD provides a protective effect on organ perfusion and circulatory stress when compared to conventional haemodialysis. The BTM (blood temperature monitor, Fresenius Medical Care) offers a way to overcome this to regulate thermal balance during dialysis and achieve a neutral thermal balance (isothermic) over the dialysis session. Other dialysis parameters will be standardised between treatment arms using blood volume monitoring (BVM) and clinical assessments.

Chief Investigator: Prof Maarten Taal

EudraCT number: N/A

ISRCTN number/ Clinical Trials.gov Number: n/a

Funder: Fresenius Medical Care Deutschland GmbH

Sponsor: Fresenius Medical Care Deutschland GmbH

Current Status: In set-up

Derby CTSU Involvement: Study Design and Protocol Development, Trial Management, Data Management, Statistics

Leg oedema in multiple sclerosis (LIMS)

People who have MS sometimes have swollen legs. This leg swelling can occur for a number of reasons, particularly if it has become difficult to walk. In these circumstances, excess water may build up in the tissues and cause the legs to become swollen. Swollen legs can be painful and uncomfortable, particularly if it is difficult to find shoes that fit. Some people also find that swollen legs make it more difficult to walk or to transfer, for instance from a wheelchair to a car. When severe, the skin can develop sores and infections that may require treatment and admissions to hospital. The first aim of our study is to estimate the proportion of people with multiple sclerosis (MS) known to the neurology or rehabilitation medicine services of one hospital who experience leg swelling. The second aim is to assess how severe the leg swelling is amongst those who have it, what factors might precipitate swelling and what problems it creates in everyday life. The third aim is to assess the extent to which leg swelling is unrecognised by patients.

Chief Investigator: Dr Vaughan Keeley

EudraCT number: N/A

ISRCTN number/ Clinical Trials.gov Number: N/A  

Funder: Multiple Sclerosis Society of Great Britain and Northern Ireland

Sponsor: Derby Teaching Hospitals NHS Foundation Trust

Current Status: In Analysis

Derby CTSU Involvement: Study design, trial management, monitoring, Data Management, Database build, Statistics

The Renal Risk in Derby Study (RRID)

This is a long-term longitudinal observational cohort study. Defining the risk of renal function decline and cardiovascular disease among patients with chronic kidney disease stage 3: a prospective study to develop renal risk scores. 

Chief Investigator: Prof Maarten Taal

EudraCT number: N/A

ISRCTN number/ Clinical Trials.gov Number: N/A  

Funder: Roche Products Limited

Sponsor: Derby Teaching Hospitals NHS Foundation Trust

Current Status: Closed to recruitment in follow up

Derby CTSU Involvement: Study design, sample size estimations, statistical analysis, manuscript preparation 

Details to be confirmed – Study in set up / contracts stage
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